JP6477449B2 - Analysis apparatus and analysis method - Google Patents

Description

  The present invention relates to an analysis apparatus and an analysis method for scientific analysis of an analysis object.

  An analyzer that can estimate the concentration and amount of a specific component (hereinafter referred to as “target component”) contained in a specimen by detecting the degree of change when the specimen and the reagent are reacted. Are known. When a chemical reaction occurs between a specimen and a reagent, the correspondence between the concentration of the target component contained in the specimen and the amount of change due to the chemical reaction is often non-linear. In addition, this correspondence may vary depending on various conditions during analysis (hereinafter referred to as “analysis conditions”). For this reason, usually, first, a calibration curve showing a correspondence relationship is created based on the amount of change when a chemical reaction is caused between a sample containing a target component of a known concentration and a reagent. The user analyzes the sample containing the target component of unknown concentration by applying the created calibration curve to the analyzer.

  In order to perform the measurement with high accuracy by the analyzer, it is preferable that the analysis conditions other than the sample are made the same as much as possible when creating the calibration curve and when analyzing the sample containing the target component of unknown concentration. However, this analysis condition cannot be completely matched. For example, it is difficult to completely match the components of a plurality of reagents with different lots. For this reason, the analysis conditions (hereinafter referred to as “reagent conditions”) due to the reagents are different among a plurality of reagents having different lots. Therefore, each time a reagent with a different lot is used, the user reworks a calibration curve before analysis. On the other hand, an attempt has been made to save the user from creating a calibration curve by creating a calibration curve at a reagent manufacturer and providing the data to the user (see, for example, Patent Document 1).

  In addition, analysis conditions (hereinafter referred to as “apparatus conditions”) caused by the analysis apparatus may be different among a plurality of analysis apparatuses. For example, the analyzer conditions used by the reagent manufacturer to create a calibration curve and the analyzer used by the user, such as the quantitative amount of the reagent, temperature, acceleration, sensitivity of the optical measurement unit, and luminescence intensity, etc. May be different. In such a case, even if the user applies the calibration curve data provided by the reagent manufacturer to the analyzer as it is, the user cannot perform the analysis with high accuracy. On the other hand, by using a correction formula for correcting the provided calibration curve data and applying the corrected calibration curve to the analyzer, the accuracy of the analysis will be improved even when the apparatus conditions are different. (For example, refer to Patent Document 2).

JP 59-10850 A JP-A-9-127122

  When a calibration curve is created by a reagent manufacturer, reagent conditions and apparatus conditions may interact to affect the calibration curve data. In this case, even if the calibration curve data provided is corrected by the correction formula described in Patent Document 2, the difference in reagent conditions and apparatus conditions between the reagent manufacturer side and the user side may not be compensated. In this case, there is a problem that the user cannot accurately analyze the sample containing the target component having an unknown concentration.

  An object of the present invention is to provide an analysis apparatus and an analysis method capable of easily and accurately estimating the amount of a target component contained in a specimen by using reagent conditions and apparatus conditions that are independent of each other. It is.

The analyzer according to the first aspect of the present invention detects a physical quantity that changes due to a reaction between a specimen and a reagent, and is a parameter that includes at least a first parameter and a second parameter, and includes reagent conditions and apparatus conditions that are independent of each other. An analyzer for calculating a ratio of a target component contained in the specimen by comparing a physical quantity with a calibration curve that can be specified based on a nonlinear function expressed by a parameter of a calibration curve to be used. Reaction means for reacting the reagent, detection means for detecting the physical quantity that changes due to the reaction between the specimen and the reagent by the reaction means, parameter holding means for holding the parameter, and detection result by the detection means And the target component included in the specimen based on the parameter held by the parameter holding means. A calibration curve collating means for calculating the ratio, an input means for inputting at least a part of the second parameter, and a parameter holding means when at least a part of the second parameter is inputted by the input means Parameter processing means for executing an update process of the parameter held by the parameter means, wherein the parameter processing means sets at least a part of the second parameter input by the input means as the new second parameter, The parameter is updated so that the first parameter held by the parameter holding unit before the second parameter is input by the input unit becomes the new first parameter.

  In the above case, the user of the analyzer calculates the ratio of the target component contained in the sample using the held first parameter and the input second parameter. Since the first parameter and the second parameter are independent, in the calibration curve specified based on the nonlinear function expressed by the parameter including these, the analysis condition of the reagent used for the analysis by the user and the analysis by the user The analysis conditions of the analyzer used in the above are appropriately reflected without causing an interaction. For this reason, the user can accurately calculate the ratio of the target component contained in the sample based on the first parameter and the second parameter.

  Even when the analysis device or reagent used by the user is changed, if only the changed parameter on one side is updated, it is not necessary to update the parameter on the other side. Therefore, for example, even when the calculation of the ratio of the target component contained in the sample is performed using a common analyzer and using different reagents, the user can easily perform the target component without re-creating a calibration curve. The ratio can be calculated.

  In the first aspect, the first parameter may be a parameter calibrated for at least one of the reaction means and the detection means, and the second parameter may be a parameter calibrated for each reagent. . In this case, among the parameters representing the calibration curve, the first parameter calibrated for each analyzer and the second parameter calibrated for each reagent are separated. For this reason, for example, when the reagent used for the analysis is changed, the user can change only the second parameter among the parameters held by the parameter holding means, and can use the first parameter of the analyzer as it is. Therefore, the user need not consider the first parameter of the analyzer used by the reagent manufacturer and the second parameter of the reagent used by the manufacturer of the apparatus.

  In the first aspect, all of the parameters may be the first parameter or the second parameter. In this case, the calibration curve is expressed only by the first parameter and the second parameter, and there is no need to consider factors other than the factor determining the first parameter and the factor determining the second parameter. Therefore, the user can appropriately specify the first parameter and the second parameter that can express the calibration curve that appropriately reflects the analysis conditions. Therefore, the user can calculate the ratio of the target component contained in the sample with higher accuracy.

  In the first aspect, the nonlinear function may be a logistic function. The chemical reaction does not proceed when there are too few target components, and when there are too many target components, the reaction proceeds quickly and the target components are quickly depleted. For this reason, a calibration curve representing a chemical reaction has a small slope when the target component is large and small, and is often represented by a curve with a large slope between them. Therefore, it is generally known that the calibration curve in such a system is well approximated by a logistic function. On the other hand, in the present invention, the calibration curve is expressed by a logistic function based on the above. For this reason, the analyzer can obtain an accurate approximate value using a simple function when calculating the ratio of the target component contained in the sample.

（但し、ａ１、ｂ１、ｃ１、ｄ１は前記第１パラメータ、ａ２、ｂ２、ｃ２、ｄ２は前記第２パラメータ、ｘは前記対象成分の割合）の関係式によって特定可能な４パラメータのロジスティック関数ｆ（ｘ）で表現されてもよい。４パラメータのロジスティック関数では、第１パラメータと第２パラメータとが原理的にほぼ分離できるような記述方法となっている。このため、４パラメータをそれぞれ第１パラメータ及び第２パラメータの積で表すことによって、柔軟な補正を行うことができる。 In the first aspect, the nonlinear function is:

(Where a1, b1, c1, and d1 are the first parameters, a2, b2, c2, and d2 are the second parameters, and x is the ratio of the target component). (X) may be used. In the four-parameter logistic function, the description method is such that the first parameter and the second parameter can be substantially separated in principle. Therefore, flexible correction can be performed by representing the four parameters by the product of the first parameter and the second parameter, respectively.

（但し、ａ、ｃ、ｄは前記第１パラメータ、ｂは前記第２パラメータ、ｘは前記対象成分の割合）の関係式によって特定可能な４パラメータのロジスティック関数ｆ（ｘ）で表現されてもよい。４パラメータのロジスティック関数では、第１パラメータと第２パラメータとが原理的にほぼ分離できるような記述方法となっている。このため、４パラメータをそれぞれ第１パラメータ及び第２パラメータで表すことによって、柔軟な補正を行うことができる。 In the first aspect, the nonlinear function is:

(Where a, c, d are the first parameter, b is the second parameter, x is the ratio of the target component) and can be expressed by a four-parameter logistic function f (x) that can be specified by the relational expression Good. In the four-parameter logistic function, the description method is such that the first parameter and the second parameter can be substantially separated in principle. Therefore, flexible correction can be performed by representing the four parameters by the first parameter and the second parameter, respectively.

Analysis method according to the second aspect of the present invention detects a physical quantity that varies by the reaction of the specimen and a reagent, the first parameter and the reagent conditions and equipment conditions independent of each other and at least includes parameter and a second parameter An analysis method for calculating a ratio of a target component contained in the specimen by comparing a physical quantity with a calibration curve that can be specified based on a nonlinear function expressed by parameters of a calibration curve to be used. Included in the sample based on the detection result by the detection unit that detects the physical quantity that changes due to the reaction between the sample and the reagent by the reaction unit that reacts with the reagent, and the parameter held by the parameter holding unit A calibration curve collating step for calculating a ratio of the target component to be inputted, and at least a part of the second parameter are inputted. An input step, and a parameter processing step for executing an update process of the parameter held by the parameter holding means when at least a part of the second parameter is inputted by the input step, the parameter processing In the step, at least a part of the second parameter input in the input step is set as the new second parameter, and is held by the parameter holding unit before the second parameter is input in the input step. The parameter is updated so that the first parameter is the new first parameter. In the second aspect, the first parameter is a parameter calibrated for at least one of the reaction means and the detection means, and the second parameter is a parameter calibrated for each reagent. Also good. According to the 2nd aspect, there can exist an effect similar to a 1st aspect.

  2nd aspect WHEREIN: The said physical quantity is each detected with respect to the at least 1 reference material from which each said physical quantity differs, The 1st parameter determination step which determines the said 1st parameter based on a detection result is further provided, Said at least 1 said The number of reference substances may be smaller than the number of parameters expressing the nonlinear function. For example, in the case of a calibration curve expressed by a function of n parameters, in order to determine the calibration curve, detection results for at least n different reference concentrations of reference substances are required. On the other hand, in the present invention, the first parameter and the second parameter are included in the parameters expressing the calibration curve. When the second parameter is known, each analyzer can determine the first parameter if there are detection results for reference substances having different known concentrations for several minutes excluding the second parameter. For this reason, the procedure required to obtain a calibration curve can be reduced.

  In the second aspect, the first parameter determination step is performed for each analyzer, and the physical quantity is detected with respect to a number of reference substances equal to or greater than the number of the first parameters to determine the first parameter. May be. For example, when there are m first parameters, the first parameter can be determined by setting m or more detection results to determine the first parameter.

  2nd aspect WHEREIN: The said physical quantity is detected with respect to the at least 1 reference material from which each said physical quantity differs, The 2nd parameter determination step which determines the said 2nd parameter based on a detection result is further provided, The said at least 1 reference | standard The number of substances may be smaller than the number of the parameters expressing the nonlinear function. For example, in the case of a calibration curve expressed by a function of n parameters, in order to determine the calibration curve, detection results for at least n different reference concentrations of reference substances are required. On the other hand, in the present invention, the first parameter and the second parameter are included in the parameters expressing the calibration curve. When the first parameter is known, each analysis apparatus can determine the second parameter if there are detection results for reference substances having different known concentrations for several minutes excluding the first parameter. For this reason, the procedure required to obtain a calibration curve can be reduced.

  In the second aspect, the second parameter determination step is performed for each of the reagents, and the physical quantity is detected for the plurality of reference substances equal to or greater than the number of the second parameters, and the second parameter is determined. May be determined. For example, when there are m second parameters, the second parameter can be determined by setting m or more detection results for determining the second parameter.

1 is a perspective view of an analyzer 1. FIG. FIG. 2 is an enlarged perspective view of an upper portion of the analyzer 1 and a block diagram showing an electrical configuration of the analyzer 1. It is a graph which shows an example of a logistic function. It is a figure which shows a 1st pre-process, a 2nd pre-process, and an analysis process. It is a flowchart which shows a 1st pre-process, a 2nd pre-process, and an analysis process.

  DESCRIPTION OF EMBODIMENTS Embodiments embodying the present invention will be described with reference to the drawings. In the following description, the upper side, lower side, lower left side, upper right side, lower right side, and upper left side of FIG. 1 are respectively referred to as the upper side, lower side, left side, right side, front side, and rear side of the analyzer 1. And

<Structure of analyzer 1>
The analyzer 1 is an apparatus that uses a test chip 2 (see FIG. 2) that can store a liquid sample and a reagent, and analyzes the ratio of the target component contained in the sample per unit amount of the sample. The ratio per unit amount of the sample is the concentration of the target component in the sample and varies depending on the chemical reaction and detection device used for the measurement, but the volume, surface area, weight or substance amount per volume, per surface area, or per weight It is an amount expressed as a concentration. In the present embodiment, as will be described later, the amount of light proportional to a predetermined area is measured by a measuring unit having a known depth, thereby estimating an amount proportional to the amount of substance (volume molar concentration) per unit volume.

  As shown in FIG. 1, the analyzer 1 includes a housing 10. The housing 10 has a box-shaped frame structure. A hole 11 </ b> A is formed in the upper portion of the housing 10. The housing 10 rotatably supports one end of a lid member 11B that is a rectangular plate material. When the other end facing the one end of the lid member 11B approaches the housing 10 by rotation, the lid member 11B covers the hole 11A. An operation unit 12 is provided on the right side of the hole 11A. The operation unit 12 includes a power switch and a plurality of operation switches. Note that an information device (such as a PC) (not shown) may be connected to the analysis apparatus 1.

  As shown in FIG. 2, the analyzer 1 includes a holder 61, a turntable 33, a rotation mechanism (not shown), an angle changing mechanism 34, a partition wall 14, a measurement unit 7, and the like. The outline of each configuration is as follows. The holder 61 is provided on the upper side of the upper plate 32. The holder 61 can be mounted with the inspection chip 2. The holder 61 is supported from below by the turntable 33. The inspection chip 2 is mainly made of a transparent synthetic resin plate. The surfaces on both sides of the plate material of the inspection chip 2 are each sealed with a transparent synthetic resin sheet. The distance (depth) between the two synthetic resin sheets 2A and 2B facing each other is uniform throughout the inspection chip 2. Between the two synthetic resin sheets 2A and 2B facing each other, a liquid channel 2C through which the specimen and the reagent accommodated in the test chip 2 can flow is formed. The rotation mechanism has a motor provided below the upper plate 32. The motor rotates the holder 61 and the inspection chip 2 by rotating the turntable 33 around the vertical axis A1 that is separated from the holder 61 and the inspection chip 2. The angle changing mechanism 34 includes a pair of rack gears 43. Each of the pair of rack gears 43 is fixed to the inner shaft 40 extending along the vertical axis A1. The pair of rack gears 43 moves up and down as the inner shaft 40 moves up and down. Each rack gear 43 is provided with a support portion 47 on the counterclockwise direction side when viewed from above. The support part 47 is provided on the upper surface of the turntable 33 and supports the holder 61 rotatably. A gear 76 formed on the holder 61 is engaged with the rack gear 43. As the gear 76 rotates as the rack gear 43 moves up and down, the holder 61 rotates about the horizontal axis A2. As the holder 61 rotates, the inspection chip 2 mounted on the holder 61 also rotates.

  In the present embodiment, the holder 61 and the inspection chip 2 rotate around the vertical axis A <b> 1 as the turntable 33 rotates, and centrifugal force acts on the holder 61 and the inspection chip 2. The rotation around the vertical axis A1 of the holder 61 and the inspection chip 2 is referred to as revolution. On the other hand, with the vertical movement of the inner shaft 40, the holder 61 and the inspection chip 2 rotate around the horizontal axis A2, and the centrifugal direction that is the direction of the centrifugal force acting on the holder 61 and the inspection chip 2 changes relatively. The rotation around the horizontal axis A2 of the holder 61 and the inspection chip 2 is referred to as rotation.

  The partition wall 14 is a cylindrical member whose upper side is closed. The partition wall 14 is provided above the upper plate 32 and outside the rotation range in which the holder 61 and the test chip 2 are rotated. The partition wall 14 covers the rotation range from the upper side. Holes 14 </ b> A and 14 </ b> B are formed in the side surface portion of the partition wall 14. The measurement part 7 performs an optical measurement with respect to a liquid mixture. The measurement unit 7 includes an emission unit 71 that emits measurement light, and a detection unit 72 that detects the measurement light emitted from the emission unit 71. The injection portion 71 is disposed on the right side of the hole 14A of the partition wall 14. The detection unit 72 is disposed on the left side of the hole 14 </ b> B of the partition wall 14. The measurement unit 7 emits measurement light from the emission unit 71. The measurement light emitted from the emission part 71 passes through the hole 14A. The measurement light that has passed through the hole 14A passes through the measurement portion formed in a part of the liquid channel 2C in the inspection chip 2 in the same direction as the opposing direction of the two synthetic resin sheets. The measurement light that has passed through the measurement part of the inspection chip 2 passes through the hole 14B. The measurement light that has passed through the hole 14B is detected by the detector 72. The measurement unit 7 outputs a signal corresponding to the intensity of the measurement light detected by the detection unit 72 to the CPU 91 described later.

  The analysis apparatus 1 further includes a CPU 91, a RAM 92, a flash memory 93, a revolution controller 97, and a rotation controller 98. The CPU 91 governs main control of the analyzer 1. A RAM 92, a flash memory 93, an operation unit 12, a revolution controller 97, a rotation controller 98, and a measurement unit 7 are connected to the CPU 91. The RAM 92 temporarily stores various data. The flash memory 93 stores a control program. The flash memory 93 stores parameters to be described later. The revolution controller 97 controls the revolution of the holder 61 and the inspection chip 2 based on an instruction from the CPU 91. The rotation controller 98 controls the rotation of the holder 61 and the inspection chip 2 based on an instruction from the CPU 91.

<Outline of centrifugation, optical measurement, and analysis>
The user injects a specimen and a reagent from an injection port (not shown) of the test chip 2. One specific example of the sample is a sample containing vitamin A as a target component. One specific example of the reagent is a latex turbid liquid used in latex agglutination turbidimetry. The user attaches the inspection chip 2 to the holder 61 and inputs a process start command from the operation unit 12. As a result, the CPU 91 executes centrifugal processing based on the control program stored in the flash memory 93.

  The outline of the centrifugation process is as follows. The CPU 91 reads drive information stored in advance in the flash memory 93 and sets the drive information in the revolution controller 97 and the rotation controller 98. The CPU 91 starts the revolution of the inspection chip 2. CPU91 maintains the revolution speed which is the moving speed of the test | inspection chip 2 to revolve at a predetermined | prescribed speed. Next, the CPU 91 changes the rotation angle. When the rotation angle of the inspection chip 2 is changed, the direction of the centrifugal force acting on the inspection chip 2 changes. The CPU 91 repeatedly changes the direction of the centrifugal force by repeatedly changing the rotation angle.

  In accordance with the revolution and rotation of the test chip 2, the specimen and the reagent injected into the test chip 2 move along the liquid channel 2C. The specimen and the reagent are quantified and mixed in the process of movement. When the specimen and the reagent are mixed, a chemical reaction occurs between the target component contained in the specimen and the reagent. The liquid mixture is stored in the measurement unit.

  After executing the centrifugation process, the CPU 91 executes the optical measurement process as follows. The CPU 91 controls the measurement unit 7 to emit measurement light from the emission unit 71. The measurement light passes through the measurement part of the inspection chip 2. The measurement light transmitted through the measurement unit is detected by the detection unit 72. The measurement unit 7 outputs a signal corresponding to the intensity of the measurement light detected by the detection unit 72 to the CPU 91. As described above, a chemical reaction occurs between the target component contained in the specimen and the reagent in the mixed solution in the measurement unit. The degree of the chemical reaction that occurs between the target component and the reagent varies depending on the amount of the target component contained in the specimen. The change in the degree of chemical reaction affects the transmittance when the measurement light passes through the mixed solution. That is, when the concentration of the target component contained in the sample changes, the intensity of the measurement light detected by the detection unit 72 also changes. Therefore, a change in the concentration of the target component contained in the specimen is detected as a change in the voltage of the signal output from the measurement unit 7. Hereinafter, the voltage of the signal output from the measurement unit 7 is referred to as “measurement voltage”.

  After the execution of the optical measurement process, the CPU 91 calculates the concentration of the target component by comparing the measurement voltage of the signal output from the measurement unit 7 with a calibration curve. The calibration curve is specified by a non-linear function expressed based on parameters stored in the flash memory 93. Hereinafter, the above processing for calculating the concentration of the target component by collating the measured voltage with the calibration curve is referred to as “analysis processing”. That is, the CPU 91 calculates the concentration of the target component contained in the sample by executing the centrifugal process, the optical measurement process, and the analysis process.

<Parameter>
The parameters stored in the flash memory 93 will be described in detail. A total of eight parameters are stored, a1, b1, c1, d1, a2, b2, c2, d2. The parameters a1, b1, c1, and d1 are stored in the flash memory 93 when the analyzer 1 is shipped from the manufacturer of the analyzer 1. These parameters and parameters a2, b2, c2, and d2 (described later) input via the operation unit 12 are for expressing a nonlinear function for specifying a calibration curve. In this embodiment, a logistic function is used as the nonlinear function.

又、（１）式において、ａ１×ａ２を「ａ」、ｂ１×ｂ２を「ｂ」、ｃ１×ｃ２を「ｃ」、及び、ｄ１×ｄ２を「ｄ」と表記した場合、（２）式によって示される。

A logistic function expressed by parameters (a1, b1, c1, d1, a2, b2, c2, d2) is expressed by equation (1). In the equation (1), x corresponds to the concentration of the target component contained in the sample. f (x) corresponds to the measured voltage. A graph showing an example of the logistic function f (x) is shown in FIG.

Further, in the formula (1), when a1 × a2 is represented as “a”, b1 × b2 as “b”, c1 × c2 as “c”, and d1 × d2 as “d”, formula (2) Indicated by.

<Relationship between concentration of target component and logistic function>
When the optical measurement process is performed by the analyzer 1, the measurement voltage changes according to the concentration of the target component contained in the sample. For example, when the concentration of the target component contained in the specimen is small, the speed of the chemical reaction between the target component and the reagent is relatively slow. As the concentration of the target component contained in the specimen increases, the speed of the chemical reaction between the target component and the reagent increases. However, if the concentration of the target component contained in the sample becomes too high, the reagent is depleted due to a chemical reaction with the target component, so that the degree of the chemical reaction between the target component and the reagent after a certain time is saturated. As described above, when the amount of the target component is large and small, the rate of change of the degree of the chemical reaction with respect to the concentration is small, and the rate of change is large during that time. It is generally known that such a trend is a good approximation to a logistic function devised as a model for population growth.

  Therefore, in the analyzer 1, a logistic function is used as a calibration curve for calculating the concentration of the target component contained in the sample. In the analyzer 1, when the signal output from the measurement unit 7 is detected in the optical measurement process, the measurement voltage is substituted into the inverse function of the expression (1) in the analysis process. Thereby, the concentration of the target component contained in the sample is calculated. Specifically, for example, in FIG. 3, when the measured voltage (f (x)) is V0, D0 is calculated as the corresponding concentration (x) based on the inverse function of equation (1).

<Relationship between parameters and analysis conditions>
Parameters for expressing a logistic function (hereinafter referred to as “logistic function parameters”) change according to differences in various conditions (hereinafter referred to as “analysis conditions”) at the time of optical measurement processing. There is a case. The analysis conditions include an analysis condition attributable to the analyzer 1 (hereinafter referred to as “apparatus condition”) and an analysis condition attributable to the reagent (hereinafter referred to as “reagent condition”). The apparatus conditions include at least one of reaction conditions and measurement conditions. Specific examples of the reaction conditions include revolutions by the rotation mechanism and rotation speed and rotation angle during rotation by the angle changing mechanism 34, temperature during analysis processing, the shape of the inspection chip 2, and the like. Specific examples of the measurement conditions include the intensity and emission angle of the measurement light emitted from the emission unit 71 of the measurement unit 7, the sensitivity of the measurement light in the detection unit 72 of the measurement unit 7, and the like. Specific examples of reagent conditions include reagent components and concentrations.

  The relationship between parameters (a1, a2, b1, b2, c1, c2, d1, d2) and analysis conditions (apparatus conditions and reagent conditions) will be described. Consider a case where the concentration x of the target component is “0” in the equation (1). In this case, the right side is a1 × a2. When the concentration x of the target component is “0”, no chemical reaction occurs between the target component and the reagent. For this reason, even when the reagent conditions are different, f (x) (= a1 × a2) matches. Therefore, it can be seen that a1 × a2 (= a) is a parameter that is not affected by the difference in the reagent conditions, in other words, a parameter that is only affected by the difference in the apparatus conditions.

  In equation (1), the limit when the concentration x of the target component is extremely large and infinite is considered. In this case, the right side is d1 × d2. When the concentration x of the target component is extremely increased, the target component that does not cause a chemical reaction with the reagent becomes dominant. For this reason, even when the reagent conditions are different, f (x) (= d1 × d2) substantially matches. Therefore, it can be seen that d1 × d2 (= d) is a parameter that is not affected by the difference in the reagent conditions, in other words, a parameter that is affected only by the difference in the apparatus conditions.

Consider a case where the concentration x of the target component is multiplied by k in the equation (1). In this case, the denominator of the second term on the right side is expressed as “(kx / (c1 × c2)) ^{(b1 × b2)} ”. The numerator and denominator of “(kx / (c1 × c2)) ^{(b1 × b2)} ” and “(kx / (c1 × c2)) ^{(b1 × b2)} ” are multiplied by “1 / k”, respectively. “(X / (c1 × c2 / k)) ^{(b1 × b2)} ” is equivalent. From this, f (x) shows the same change when the concentration x of the target component is multiplied by k and c1 × c2 is multiplied by 1 / k. Therefore, it can be said that c1 × c2 is a parameter representing the quantitative ratio of the specimen to the reagent. Therefore, it can be seen that c1 × c2 (= c) is a parameter that is not affected by the difference in the reagent conditions, in other words, a parameter that is affected only by the difference in the apparatus conditions.

  On the other hand, the case where “b1 × b2” is changed in the equation (1) is illustrated. In this case, the slope of f (x) changes according to the concentration x of the target component. The change in the slope indicates a change in the reaction rate of the reagent with respect to the target component, and is affected by the component of the reagent. Therefore, it can be seen that b1 × b2 (= b) is a parameter that is not affected by the difference in the apparatus conditions, in other words, a parameter that is affected only by the difference in the reagent conditions.

  As described above, it can be understood that the parameters of the logistic function expressed by the equations (1) and (2) are all parameters that are influenced only by either the apparatus condition or the reagent condition. Hereinafter, a1, b1, c1, and d1 are referred to as first parameters. a2, b2, c2, and d2 are referred to as second parameters. a1 × a2, c1 × c2, and d1 × d2 are affected only by apparatus conditions. b1 × b2 is affected only by the reagent conditions.

<Pre-process>
In the present embodiment, the first parameter is determined by the manufacturer of the analyzer 1 (hereinafter referred to as “apparatus maker”). On the other hand, the second parameter is determined by the manufacturer of the reagent P (hereinafter referred to as “reagent manufacturer”). The user uses the analyzer 1 and the reagent P, and calculates the concentration of the target component by using parameters determined by the apparatus manufacturer and the reagent manufacturer. Hereinafter, the process in which parameters are determined by the apparatus manufacturer and the reagent manufacturer is referred to as “pre-process”. The device manufacturer and the reagent manufacturer may be the same manufacturer.

  Details of the previous process will be described with reference to FIGS. The reagent P is a reagent that causes a chemical reaction with the target component q contained in the specimen Q. The analyzer 1 can calculate the concentration of the target component q by using the sample Q and the reagent P. A plurality of analyzers 1 manufactured by an apparatus manufacturer are referred to as “analyzers 1A and 1B”. The analysis apparatuses 1A and 1B have different apparatus conditions. A plurality of reagents P manufactured by a reagent manufacturer are denoted as “reagents P1, P2”. Reagent conditions for reagents P1 and P2 are different.

<First pre-process>
A pre-process (hereinafter referred to as “first pre-process”) performed by the device manufacturer will be described. In the first pre-process, the first parameters a1, b1, c1, d1 stored in advance in the flash memory 93 of the analyzer 1 are determined. Details are as follows.

  The analyzer 1A is used by the device manufacturer. Three specimens Q having a known concentration of the target component q are prepared. Hereinafter, each specimen is denoted as “Q1, Q2, Q3”. The concentrations of the target component q contained in each of the samples Q1, Q2, and Q3 are referred to as “concentrations D1, D2, and D3”. In addition, a reagent P1 manufactured by a reagent manufacturer is prepared. Although details will be described later, a medium (data sheet or the like) on which the second parameters a2, b2, c2, and d2 are printed is attached to the reagent P1. The second parameter is input to the analyzer 1A through the operation unit 12.

  In the analyzer 1A, the sample Q1 and the reagent P1 are used, and a centrifugation process is executed (S11). In the course of the centrifugation process, the sample Q1 and the reagent P1 injected into the test chip 2 are quantified and mixed. A chemical reaction occurs between the target component q and the reagent P1. The liquid mixture is stored in the measurement unit. After the execution of the centrifugation process, the optical measurement process is executed as follows (S13). Measurement light is emitted from the emission part 71 of the measurement part 7. The measurement light passes through the measurement unit of the inspection chip 2 and is detected by the detection unit 72 of the measurement unit 7. A signal corresponding to the intensity of the detected measurement light is output from the measurement unit 7. The concentration D1 of the target component q included in the sample Q1 and the measurement voltage V1 of the signal output from the measurement unit 7 are associated and stored in association with the RAM 92. Hereinafter, the concentration and the measurement voltage stored in association with each other are represented as (D1, V1). The samples Q2 and Q3 are used, respectively, and the centrifugation process and the optical measurement process are executed in the same manner. As a result, (D2, V2) (D3, V3) is stored in the RAM 92.

  (D1, V1) (D2, V2) (D3, V3) stored in the RAM 92 are substituted as (x, f (x)) in the equation (2). Further, the parameter b2 printed on the medium attached to the reagent P1 is substituted as the parameter b in the equation (2). As a result, three equations including parameters a, c, and d as variables are defined. Since there are three variables and three equations, the parameters a, c and d are determined by solving these as simultaneous equations (S15). The determined parameters a, c, and d are stored in the flash memory 93 as a1, c1, and d1 among the first parameters of the analyzer 1A. Here, “1” is stored as b1 in the first parameter in the flash memory 93 (S17). The reason that “1” is stored in the flash memory 93 as the parameter b1 is that when the parameter b2 is input via the operation unit 12 in the analysis process to be described later performed by the user, b1 × b2 This is to make the calculation result coincide with b2. Details will be described later. The analyzer 1A is shipped to the user with the first parameters a1, b1, c1, d1 stored in the flash memory 93.

  Note that the first pre-process is executed for each of the plurality of analysis apparatuses 1 manufactured by the apparatus manufacturer. For this reason, it can be said that the first parameter is a parameter calibrated for each analyzer 1. The plurality of analyzers 1 have different apparatus conditions. The apparatus conditions include at least one of reaction conditions and measurement conditions. For this reason, the first parameter corresponds to a parameter calibrated for at least one of the reaction condition and the measurement condition of each analyzer 1.

<Second pre-process>
A pre-process (hereinafter referred to as “second pre-process”) performed by the reagent manufacturer will be described. In the second pre-process, the second parameters a2, b2, c2, d2 to be printed on a medium such as a data sheet attached to the reagent P are determined. Details are as follows.

  The analyzer 1B is used at the reagent manufacturer. Note that the first parameter is stored in the flash memory 93 of the analyzer 1B as described in the first previous step. One specimen Q having a known concentration of the target component q is prepared. Hereinafter, this specimen is referred to as specimen Q4. The concentration of the target component q contained in the sample Q4 is referred to as a concentration D4. In addition, reagent P2 is prepared.

  In the analyzer 1B, the sample Q4 and the reagent P2 are used, and centrifugation is performed (S21). In the course of centrifugation, the specimen Q4 and the reagent P2 injected into the test chip 2 are quantified and mixed. A chemical reaction occurs between the target component q and the reagent P2. The liquid mixture is stored in the measurement unit. After the centrifugation process, an optical measurement process is performed (S23). In the optical measurement process, a signal corresponding to the intensity of the measurement light detected by the detection unit 72 is output from the measurement unit 7. The concentration D4 of the target component q contained in the sample Q4 and the measurement voltage V4 of the signal output from the measurement unit 7 are associated and stored in the RAM 92 as (D4, V4).

  (D4, V4) stored in the RAM 92 is substituted as (x, f (x)) in the equation (2). Further, a1, c1, and d1 among the first parameters stored in the flash memory 93 are substituted as the parameters a, c, and d in the equation (2), respectively. Thereby, an equation including the parameter b as a variable is defined. By solving this equation, the parameter b is determined (S25). The determined parameter b is printed on the medium as b2 of the second parameters of the reagent P2. Further, among the second parameters, “1” is printed on the medium as a2, c2, and d2 (S27). The reason that “1” is printed as the parameters a 2, c 2, and d 2 is that the parameters a 2, c 2, and d 2 are input to the analyzer 1 via the operation unit 12 in an analysis process described later performed by the user. In this case, the calculation results of a1 × a2, c1 × c2, and d1 × d2 are made to coincide with a1, c1, and d1, respectively. Details will be described later. The reagent P2 is shipped to the user with the medium on which the second parameter is printed attached.

  The second pre-process is executed for each of the plurality of reagents P manufactured by the reagent manufacturer. For this reason, the second parameter corresponds to a parameter calibrated for each reagent P.

<Analysis process>
An analysis process performed by the user will be described. The user prepares the analysis apparatus 1A shipped from the apparatus manufacturer. As described in the first pre-process, the flash memory 93 of the analyzer 1A stores the first parameters a1, b1, c1, and d1. The user also prepares the reagent P2 shipped from the reagent manufacturer. As described in the second previous step, the medium on which the second parameters a2, b2, c2, and d2 are printed is attached to the reagent P2. The user also prepares a specimen Q whose concentration of the target component q is unknown. Hereinafter, this sample is referred to as “sample Qx”. The concentration of the target component q contained in the sample Qx is expressed as “Dx”.

  The user inputs the second parameter via the operation unit 12 of the analyzer 1A. The input second parameter is received by the analyzer 1A (S31). The parameters stored in the flash memory 93 are updated with the original first parameters a1, b1, c1, and d1 and the input second parameters a2, b2, c2, and d2. The input second parameters a2, b2, c2, and d2 become new second parameters a2, b2, c2, and d2, respectively (S33).

  When the process of S33 is first executed in the analyzer 1A, the second parameter is not stored in the flash memory 93 (see the first previous process). In this case, the input second parameter is newly stored in the flash memory 93 by the process of S33. On the other hand, when the second and subsequent processing of S33 is executed in the analyzer 1A, the second parameter is stored in the flash memory 93 by the previous processing of S33, so that it is stored in the flash memory 93 as described above. The updated parameters are updated with the original first parameters and the input second parameters.

  When the first parameter is stored in the flash memory 93 in the first pre-process, any second parameter may be stored in the flash memory 93 at the same time. In this case, even when the process of S33 is first executed in the analysis apparatus 1A, the parameters stored in the flash memory 93 are updated with the original first parameters and the input second parameters.

  In the analyzer 1A, the sample Qx and the reagent P2 are used to perform centrifugation (S35). In the course of centrifugation, the specimen Qx and the reagent P2 are quantified and mixed. A chemical reaction occurs between the target component q and the reagent P2. The liquid mixture is stored in the measurement unit. After the centrifugal process is executed, an optical measurement process is executed (S37). In the course of the optical measurement process, a measurement voltage of a signal corresponding to the intensity of the measurement light is detected.

  The logistic function is expressed based on the first parameters a1, b1, c1, d1 and the second parameters a2, b2, c2, d2 stored in the flash memory 93. As described in the first and second previous steps, “1” is set for each of the parameter b1 and the parameters a2, c2, and d2. Therefore, since a1 * a2 = a1, b1 * b2 = b2, c1 * c2 = c1, d1 * d2 = d1 in the expression (1), the logistic function is a = a1, b = b2, c in the expression (2). = C1, d = d1 is substituted. As described above, by setting the constant “1” for the specific parameter, only the apparatus parameter of the first parameter and only the reagent parameter of the second parameter are substantially reflected as the coefficients of the calibration curve. It is like that.

  The detected measurement voltage is substituted as f (x) in the inverse function of equation (2) into which the parameters are substituted. As a result, the concentration Dx of the target component q contained in the sample Qx is calculated (S39). Information indicating the calculated concentration Dx is output to the information device connected to the analyzer 1A (S41).

<Operation and effect of this embodiment>
In the above case, the analyzer 1 expresses a logistic function by the first parameter stored in the flash memory 93 and the second parameter input via the operation unit 12, and a calibration curve specified by this logistic function. The concentration of the target component q contained in the sample Q is calculated by collating the measured voltage. a1 × a2, c1 × c2, and d1 × d2 are affected only by the apparatus conditions, and b1 × b2 is affected only by the reagent conditions. That is, both are independent parameters. The logistic function expressed by these parameters appropriately reflects the reagent conditions of the reagent P used for analysis by the user and the apparatus conditions of the analyzer 1 used for analysis by the user. Therefore, the user can accurately calculate the concentration of the target component q contained in the sample Q.

  When the analysis device 1 used by the user is changed, the first parameter stored in the flash memory 93 of the changed analysis device 1 is applied as a parameter expressing the logistic function. When the reagent P used by the user is changed, the second parameter printed on the medium attached to the changed reagent P is applied as a parameter expressing the logistic function. Thus, even when the analyzer 1 or the reagent P is changed, only the changed first parameter of the analyzer 1 or the second parameter of the reagent P among the parameters expressing the logistic function may be updated. Therefore, for example, even when the calculation of the concentration of the target component q contained in the specimen Q is performed using a different analyzer 1 or using a different reagent P, the user can calculate the concentration of the target component q. Calculation can be performed easily. Specifically, for example, the user calibrates each analyzer 1 and reagent P even when the reagent P1 used when determining the first parameter of the analyzer 1A is different from the reagent P2 used by the user at the time of analysis. This makes it possible to perform accurate analysis without having to redo. In addition, even when the analyzer 1B used when determining the second parameter of the reagent P2 is different from the analyzer 1A used by the user at the time of analysis, the user recalibrates the analyzer 1 and each reagent P. Therefore, it is possible to perform an accurate analysis.

  In the above, the parameter expressing the logistic function is separated into the first parameter calibrated for each analyzer 1 and the second parameter calibrated for each reagent P. For this reason, for example, when the reagent P used for the analysis is changed, the user changes the second parameter stored in the flash memory 93 to the second parameter printed on the medium attached to the reagent P to change the logistic function. Can be expressed. Therefore, the user does not need to consider the first parameter of the analyzer 1 used by the reagent manufacturer. In addition, for example, when the analysis device 1 used for analysis is changed, the user can express the logistic function using the first parameter stored in the flash memory 93 as it is. The user does not need to consider the second parameter of the reagent P used by the apparatus manufacturer.

  If there is a parameter in which the apparatus condition and the reagent condition interact, it causes a measurement error, which is not preferable. On the other hand, the logistic function expressed by the expression (1) or (2) is expressed only by the first parameter and the second parameter. It is not necessary to consider the interaction between the apparatus conditions for determining the first parameter and the reagent conditions for determining the second parameter. For this reason, the user can appropriately express the logistic function in which the analysis condition is appropriately reflected based on the first parameter and the second parameter. Therefore, the user can estimate the concentration of the target component q contained in the sample Q with higher accuracy.

  The chemical reaction between the target component q and the reagent P contained in the specimen Q does not proceed when the target component q is too small, and when the target component q is too large, the reaction proceeds quickly and the target component is quickly depleted. For this reason, a calibration curve representing a chemical reaction has a small slope when the target component is large and small, and is often represented by a curve with a large slope between them. Therefore, it is generally known that the calibration curve in such a system is well approximated by a logistic function. For this reason, in this embodiment, the calibration curve is expressed by a logistic function. As a result, the analyzer 1 can accurately calculate the concentration of the target component q contained in the sample Q.

  In the above embodiment, the calibration curve is represented by a 4-parameter logistic function. In the four-parameter logistic function, the description method is such that the first parameter and the second parameter can be substantially separated in principle. Therefore, flexible correction can be performed by representing the four parameters by the first parameter and the second parameter, respectively.

  In the case of a logistic function represented by a function of four parameters (a1 × a2, b1 × b2, c1 × c2, d1 × d2), in order to determine the parameters, at least four measured voltages for the analyte Q of different known concentrations Cost. On the other hand, in the case of the above embodiment, a1 × a2 = a1, b1 × b2 = b2, c1 × c2 = c1, and d1 × d2 = d1, so the logistic function is a = a1, b in equation (2). = B2, c = c1, and d = d1. That is, three parameters a1, c1, and d1 determined in the first previous process and one parameter b2 determined in the second process are included. In the first pre-process, the parameter b2 is input via the operation unit 12. For this reason, if there are measurement voltages for three different known concentrations of the specimen Q (Q1, Q2, Q3) in the first pre-process, the parameters a1, c1, and d1 can be determined. For this reason, the apparatus manufacturer can reduce the procedure necessary for obtaining the first parameter for expressing the logistic function. In the second pre-process, the parameters a1, c1, and d1 are stored in advance in the flash memory 93 of the analyzer 1. For this reason, if there is a measurement voltage for one specimen Q (Q4) having a known concentration in the second pre-process, the parameter b can be determined. For this reason, the reagent manufacturer can reduce the procedure required to obtain the second parameter for expressing the logistic function.

<Modification>
The present invention is not limited to the above embodiment, and various modifications can be made. In the embodiment described above, the analysis process is executed by the CPU 91 of the analyzer 1, and the concentration of the target component q contained in the sample Q is calculated. On the other hand, the calculation of the concentration of the target component q contained in the sample Q may be executed by an information device connected to the analyzer 1. Specifically, for example, the first parameter stored in the flash memory 93 of the analyzer 1 in the above may be stored in the memory of the information device. The second parameter printed on the medium attached to the reagent P may be input to the information device by the user. The CPU of the information device may update the parameter stored in the memory with the original first parameter and the input second parameter. Accordingly, the CPU of the information device may use the input second parameter as a new second parameter. The CPU of the information device may specify the logistic function by the same method as described above based on the first parameter stored in advance in the memory and the input second parameter. The analysis device 1 may perform centrifugal processing and optical measurement processing, and output data indicating the measurement voltage to the information device. The CPU of the information device may acquire the measurement voltage based on the data output from the analysis device 1. The CPU of the information device may calculate the concentration of the target component q by applying the acquired measurement voltage to the logistic function expressed based on the first parameter and the second parameter stored in the memory. .

  The analyzer 1 may have a display unit such as a liquid crystal display. When the CPU 91 calculates the concentration of the target component q contained in the sample Q, the CPU 91 may display the calculation result on the display unit.

  In the above, the first parameter is stored in advance in the flash memory 93 of the analyzer 1. The first parameter may be overwritten and updated with the same value at a timing at which the first parameter is updated in response to the input of the second parameter. The first parameter may be printed on a medium (for example, an instruction manual or a warranty) attached to the analysis apparatus 1. The user of the analysis apparatus 1 may input the first parameter stored in the medium to the analysis apparatus 1 via the operation unit 12. The CPU 91 of the analyzer 1 may update the parameters stored in the flash memory 93 with the input first parameter and second parameter. That is, the CPU 91 may use the input first parameter and second parameter as the new first parameter and second parameter. In the above description, the parameters stored in the flash memory 93 may be updated with only a part of the input first parameter and second parameter.

  In the above, the second parameter is printed on the medium attached to the reagent P. The second parameter may be printed on the medium as a two-dimensional barcode, for example. An RFID may be used as a medium for storing the second parameter. The CPU 91 of the analyzer 1 may update the parameter stored in the flash memory 93 with the original first parameter and the second parameter read from the RFID. That is, the CPU 91 may use the second parameter read from the RFID as a new second parameter.

  The analyzer 1 detects a change in transmittance due to a chemical reaction between the specimen Q and the reagent P by optical measurement, and calculates the concentration of the target component q contained in the specimen Q. On the other hand, the analyzer 1 may calculate the concentration of the target component q contained in the sample Q by detecting a change in another physical quantity caused by a chemical reaction between the sample Q and the reagent P. For example, the analyzer 1 detects the concentration of the target component q by detecting a change in light, a change in conductivity, a change in color, etc. when light is emitted in response to a chemical reaction between the specimen Q and the reagent P. It may be calculated. In the analyzer 1, a function other than the logistic function may be used as the calibration curve. The apparatus conditions are not limited to at least one of reaction conditions and measurement conditions. The apparatus conditions may include other analysis conditions based on individual differences of the analysis apparatus 1.

  When the first parameter is stored in the flash memory 93 in S17 of the first preprocessing, “1” is stored as b1. On the other hand, b2 printed on the medium attached to the used reagent P1 may be stored in the flash memory 93 as b1. In S27 of the second preprocessing, when the second parameter is printed on the medium, “1” is printed as a2, c2, and d2. On the other hand, a1, c1, and d1 stored in the flash memory 93 of the used analyzer 1B as a2, c2, and d2 may be printed on the medium as a2, c2, and d2, respectively.

  In the flash memory 93 of the analyzer 1, all parameters necessary for expressing the logistic function are stored. On the other hand, the flash memory 93 may store only a part of the first parameter and the second parameter. For example, a parameter for which “1” is set in the above-described embodiment may be omitted. In this case, a1, c1, and d1 may be stored as the first parameter, and b2 may be stored as the second parameter. If a = a1, b = b2, c = c1, and d = d1, equation (1) becomes the form of equation (2). Alternatively, parameters other than those for which “1” is set in the embodiment may be omitted. In this case, the user may perform a pre-process for specifying the remaining parameters before starting the analysis.

  As a parameter necessary for expressing the logistic function, another parameter that the apparatus condition and the reagent condition interact to influence each other may be included. The logistic function is not limited to the expression format described above, and may be expressed in other expression formats. In this case, the number of parameters for expressing the logistic function is not limited to four. For example, the number of parameters affected only by the difference in reagent conditions is not limited to one, and may be two or more. At this time, the second parameter printed on the medium attached to the reagent P may be a part of two or more.

  In the first pre-process executed by the apparatus manufacturer, the number of samples Q used when determining the parameters a1, c1, and d1 is not limited to three, and may be four or more. For example, when the number of specimens Q is four, b may be specified in addition to the parameters a, c, and d by solving simultaneous equations including four equations. The parameters a, b, c, and d specified at the time of shipment of the analyzer 1 may be stored in the flash memory 93 as the first parameters a1, b1, c1, and d1, respectively.

  In the second pretreatment executed by the reagent manufacturer, the number of samples Q used when determining the parameter b2 is not limited to one, and may be two or more. For example, when the number of specimens Q is four, a, c, and d may be specified in addition to the parameter b by solving simultaneous equations composed of four equations. When the reagent P is shipped, the specified a, b, c, and d may be printed on the medium as the second parameters a2, b2, c2, and d2, respectively, and attached to the reagent P.

  In the first pre-process performed by the apparatus manufacturer, a plurality of a1, c1, and d1 may be determined by using a plurality of reagents P. In this case, an average value of each of the determined a1, c1, and d1 may be calculated and stored in the flash memory 93 of the analyzer 1. In the second pre-process executed at the reagent manufacturer, a plurality of b2 may be determined by using a plurality of analyzers 1. In this case, the average value of the plurality of determined b2 may be calculated and printed on the medium attached to the reagent P.

<Others>
In the analyzer 1, the configuration (holder 61, turntable, rotation mechanism, angle changing mechanism 34) for mixing the sample and the reagent to cause the chemical reaction between the target component and the reagent is an example of the “reaction means” in the present invention. It is. The configuration for performing the optical measurement process (measurement unit 7) is an example of the “detection means” in the present invention. The flash memory 93 is an example of the “parameter holding unit” in the present invention. The CPU 91 that performs the process of S39 is an example of the “calibration curve collating unit” in the present invention. The operation unit 12 is an example of the “input unit” in the present invention. The CPU 91 that performs the processing of S33 is the “parameter processing means” of the present invention. The process of S33 is an example of the “parameter processing step” in the present invention. The process of S39 is an example of the “calibration curve collating step” in the present invention. The process of S31 is an example of the “input step” in the present invention. The process of S15 is an example of the “first parameter determination step” in the present invention. The process of S25 is an example of the “second parameter determination step” in the present invention. Samples Q1 to Q3 used in the first pre-process and sample Q4 used in the second pre-process are examples of the “reference substance” in the present invention.

1, 1A, 1B: Analysis device 2: Inspection chip 7: Measurement unit 12: Operation unit 34: Angle changing mechanism 91: CPU
93: Flash memory

Claims (12)

A non-linear function expressed by a calibration curve parameter that detects a physical quantity that changes due to a reaction between a specimen and a reagent, and that includes at least a first parameter and a second parameter and that uses a reagent condition and an apparatus condition that are independent of each other. A calibration curve that can be identified based on the physical quantity and calculating the ratio of the target component contained in the sample,
Reaction means for reacting the specimen and the reagent;
Detection means for detecting the physical quantity that changes due to the reaction between the specimen and the reagent by the reaction means;
Parameter holding means for holding the parameters;
A calibration curve matching means for calculating a ratio of the target component contained in the sample based on a detection result by the detection means and the parameter held by the parameter holding means;
Input means for inputting at least a part of the second parameter;
Parameter processing means for executing update processing of the parameter held by the parameter holding means when at least a part of the second parameter is inputted by the input means;
The parameter processing means includes
At least a part of the second parameter input by the input means is set as the new second parameter,
The analysis is characterized in that the parameter is updated so that the first parameter held by the parameter holding unit before the second parameter is input by the input unit becomes the new first parameter. apparatus.   2. The first parameter is a parameter calibrated for at least one of the reaction means and the detection means, and the second parameter is a parameter calibrated for each reagent. The analyzer described in 1.   The analysis apparatus according to claim 1, wherein all the parameters are the first parameter or the second parameter.   The analysis apparatus according to claim 1, wherein the nonlinear function is a logistic function. The nonlinear function is

(Where a1, b1, c1, and d1 are the first parameters, a2, b2, c2, and d2 are the second parameters, and x is the ratio of the target component).
The analysis apparatus according to claim 4, wherein the analysis apparatus is expressed by a four-parameter logistic function f (x) that can be specified by the relational expression: The nonlinear function is

(Where a, c, d are the first parameter, b is the second parameter, and x is the ratio of the target component)
6. The analysis apparatus according to claim 4, wherein the analysis apparatus is expressed by a four-parameter logistic function f (x) that can be specified by the relational expression: A non-linear function expressed by a calibration curve parameter that detects a physical quantity that changes due to a reaction between a specimen and a reagent, and that includes at least a first parameter and a second parameter and that uses a reagent condition and an apparatus condition that are independent of each other. An analytical method for calculating a ratio of a target component contained in the specimen by comparing a calibration curve that can be specified based on the physical quantity,
Based on the detection result by the detection unit that detects the physical quantity that changes due to the reaction between the sample and the reagent by the reaction unit that reacts the sample and the reagent, and the parameter held by the parameter holding unit, A calibration curve matching step for calculating a ratio of the target component contained in the specimen;
An input step in which at least a part of the second parameter is input;
A parameter processing step of executing an update process of the parameter held by the parameter holding means when at least a part of the second parameter is input by the input step;
The parameter processing step includes
At least a part of the second parameter input by the input step is set as the new second parameter,
The first parameter that has been held by the parameter holding means before said second parameter by said input step is input, to a new first parameter, you and updates the parameters minute析方method.   8. The first parameter is a parameter calibrated for at least one of the reaction means and the detection means, and the second parameter is a parameter calibrated for each reagent. The analysis method described in 1. A first parameter determining step of detecting the physical quantity with respect to at least one reference material having different physical quantities, and determining the first parameter based on a detection result;
The analysis method according to claim 8, wherein the number of the at least one reference material is smaller than the number of the parameters expressing the nonlinear function. The first parameter determining step includes:
The analysis method according to claim 9, wherein the analysis is performed for each analysis device, and the first parameter is determined by detecting the physical quantity with respect to a number of reference substances equal to or greater than the number of the first parameters. . A second parameter determining step of detecting the physical quantity with respect to at least one reference substance having different physical quantities, and determining the second parameter based on a detection result;
The analysis method according to claim 8, wherein the number of the at least one reference material is smaller than the number of the parameters expressing the nonlinear function. The second parameter determining step includes:
The analysis method according to claim 11, wherein the analysis is performed for each reagent, and the physical parameter is detected with respect to a number of reference substances equal to or greater than the number of the second parameters, and the second parameters are determined. .

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